Senior CSV / Validation Specialist

• 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
• Mandatory Experience in Lean and/or Agile approaches
• Experience in leading validation for projects and systems maintenance
• Experience in authoring validation plans, reports and deliverable registries
• Experience in authoring or reviewing validation related deliverables, records and other evidences
• Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
• Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
• Proficiency in gSuite
• Basic knowledge of SAP and MES systems and the interfacing thereof
• Hands-on experience with Retina or JIRA (Backlog Management)
• Hands-on experience with ServiceNow (Incident, Change, Knowledge Management)
• Awareness of common development technologies and governance processes impacting validation approaches
• Professional Scrum or SAFe Certification is an advantage (mandatory to be obtained within 6 months after joining)
• Communication skills, English language mandatory (C1)
• Ability to explain complex concepts with clarity and simplicity
• Strong verbal, written, and interpersonal communication skills
• Assertiveness, conflict management skills, leadership skills
• Follow-through and persistence to chase up busy stakeholders for input/signatures
• Ability to share knowledge and guide others

Nice to have:

• SAP experience

• Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems
• Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance
• Author validation plans/reports, reviews test plans/reports (and other deliverables) to assess and notify that system is ready to go live
• Lead and author system and functional risk assessments
• Verification of testing plans, activities, deliverables and records
• Provide consultancy on test related deviations and corrective actions
• Assess changes to determine potential impact to the validated state of the computerized system
• Support system maintenance with validated state and permanent audit readiness
• Lead and author system periodic review according to procedure
• Provide input and guidance for a computerized system retirement planning
• Coordinate and advise on all validation activities on a global level/organizational level for system/project
• Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
• Participate actively in validation discussions, provide consultancy for all validation related questions
• Assures strategic/essential oversight over validation support within the department and provides support/consultancy for the team and within the global organization if necessary
• Support system audit/inspection preparation and execution as CSV subject matter expert
• Observe governance processes, escalates area for improvement
• Prepares recommendations for process optimization in his/her area of influence
• Collaborate closely with Product Owner, Scrum Master, Architects, Developers, Business Owners and Tester Team (Leads)
• Work collaboratively in cross-functional teams to achieve milestones and goals